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FDA Links -- About CDER/FDA News
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FDA approves Gleevec (imatinib) for expanded use in
patients with rare gastrointestinal cancer (2/1/2012)
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Pediatric List of Determinations Including Written
Request
(updated 2/1/2012)
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FDA approves Kalydeco to treat rare form of
cystic fibrosis (1/31/2012)
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MedWatch Safety Alert: Treanda (bendamustine
HCL): Recall - Particulate Matter in Vial (1/30/2012)
- FDA Press Release:
Department of Justice files consent decree of permanent
injunction against Ranbaxy
(1/26/2012)
- eCTD:
FDA Portable Document Format (PDF) Specifications
(1/25/2012)
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Attention Deficit Hyperactivity Disorder
(ADHD): Not Just for Kids
(1/25/2012)
- FDA Drug Safety Podcast for
Healthcare Professionals:
New risk factor for Progressive Multifocal
Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
(1/25/2012)
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Manual of Policies and
Procedures (MAPP)
6730.1 (PDF - 64KB) Use of Review Templates in the
Office of Surveillance and Epidemiology
(updated 1/24/2012)
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Drug Innovation: An ongoing update of
FDA’s Center for Drug Evaluation and Research's novel drug approvals
of calendar year 2012 (1/18/2012)
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FDA approves Voraxaze (glucarpidase) to treat patients
with toxic methotrexate levels
(1/18/2012)
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Inactive Ingredients Database Download
(updated 1/18/2012)
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The Adverse Event Reporting System (AERS): Latest Quarterly Data Files
(updated 1/17/2012)
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Notice of Risks of Purchasing Unapproved Injectable
Cancer Medications (PDF - 31KB)
(1/13/2012)
- FDA/Drug
Information Association (DIA) Cardiovascular Safety and
State-of-the-art Development Issues, April 17-18, 2012, Washington
Marriott, 1221 22nd St. NW, Washington, DC 20037
Meeting information
(1/13/2012)
- FDA Drug
Safety Communication:
New
Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
(1/13/2012)
- FDA Drug
Safety Podcast for Healthcare Professionals:
Update- Preliminary findings from ongoing investigations of
CardioGen-82
(1/13/2012)
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Publications on Genomics
(updated 1/13/2012)
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Transcript: Public Meeting on Proposed
Recommendations for a Human Generic Drug User Fee (PDF - 276KB)
(1/11/2012)
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Office of Generic Drugs: Chemistry and Bioequivalence
Review Teams
(updated 1/11/2012)
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Suitability Petitions
(updated 1/11/2012)
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First-Time Generic Drug Approvals - December 2011
(updated 1/11/2012)
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Certain Opiate Products Made for Endo Pharmaceuticals
(1/9/2012)
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Drug Firm Annual Registration Status
(updated 1/9/2012)
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Drug Firm Annual Registration Status
Download File (ZIP - 380KB)
(updated 1/9/2012)
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Approved Risk Evaluation and Mitigation Strategies
(REMS) (updated 1/5/2012)
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Electronic Common Technical Document (eCTD)
(updated 1/5/2012)
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eCTD Validation Specifications
(updated 1/5/2012)
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FDA Statement on recently terminated clinical trial
with Doribax (doripenem)
(1/5/2012)
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Office of Prescription Drug Promotion (OPDP)
(updated 1/5/2012)
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OPDP Research (updated
1/5/2012)
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Comunicaciones de la FDA sobre la seguridad de los
medicamentos en español
(1/4/2012)
- Comunicado de la FDA sobre la seguridad de los medicamentos:
El uso de antidepresivos con inhibidor selectivo de recaptación de
serotonina (SSRI por sus siglas en inglés) durante el embarazo y
reportes de afecciones cardiacas y pulmonares poco comunes en recién
nacidos
- Manual of
Policies and Procedures (MAPP)
4141.2 (PDF -100KB) Tracking of Significant Safety issues in Marketed
Drugs -- Use of the DARRTS Tracked Safety Issues
(updated 1/4/2012)
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National Drug Code Directory Data File Download
(updated 1/4/2012)
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ANDA Filing Checklist for Completeness and
Acceptability (PDF - updated 1/3/2012)
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Drug Firm Annual Registration Status
(updated 1/3/2012)
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Drug Firm Annual Registration Status
Download File (ZIP - 384KB)
(updated 1/3/2012)
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Questions and Answers: FDA approves a
class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal
immediate-release fentanyl (TIRF) medicines
(12/29/2011)
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FDA Alerts Pharmacists and Health Care
Professionals to Potential for Injury when Dispensing the
Similar-Sounding Drugs Durezol and Durasal
(12/28/2011)
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Drug Development Tools (DDT) Qualification
Program (12/28/2011)
- Manual of Policies and
Procedures (MAPP)
6002.4 Government-Issued Nonaccountable Personal Property (PDF -
110KB) (12/23/2011)
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Comunicaciones de la FDA sobre la seguridad de los
medicamentos en español (Posted:12/22/2011)
- Comunicado de la FDA sobre la
seguridad de los medicamentos:
Actualización del estudio de seguridad de medicamentos usados para
tratar el Trastorno de Deficiencia de Atención e Hiperactividad (ADHD
por sus siglas en inglés) en adultos
- Comunicado de la FDA sobre la
seguridad de los medicamentos:
Estudio de seguridad de informes posteriores al lanzamiento al mercado
sobre eventos de hemorragias severas con el anticoagulante Pradaxa (dabigatrán
etexilato mesilato)
- Comunicado de la FDA sobre la
seguridad de los medicamentos:
Modificación a la limitación de dosis para Zocor (simvastatina) cuando
se toma con amiodarona
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FDA expands use of HIV drug Isentress to
children and adolescents (Posted:12/22/2011)
- FDA Drug
Safety Podcast for Healthcare Professionals:
Review update of Multaq (dronedarone) and increased risk of death and
serious cardiovascular adverse events (Posted:12/21/2011)
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Questions and Answers on Current Good Manufacturing
Practices, Good Guidance Practices, Level 2 Guidance - Production and
Process Controls(updated 12/21/2011)
- FDA Drug
Safety Communication:
Safety review of a reported death after the first dose of Multiple
Sclerosis drug Gilenya (fingolimod) (12/20/2011)
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Bioresearch Monitoring Information System (BMIS)
Download File
(updated 12/20/2011)
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Drug Firm Annual Registration Status
(updated 12/20/2011)
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Drug Firm Annual Registration Status Download File (ZIP
- 390KB)
(updated 12/20/2011)
- FDA Drug
Safety Communication:
Review update of Multaq (dronedarone) and increased risk of death and
serious cardiovascular adverse events
(12/19/2011)
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FDA Drug Safety Podcast for Healthcare Professionals:
Revised dose limitation for Zocor (simvastatin) when taken with
amiodarone
(12/16/2011)
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Prescription Drug User Fee Act (PDUFA) The FY 2011 Clean-Up
Product and Establishment Fee Invoices were mailed Friday, December
16, 2011. Full payment of the invoice is due in
30 days. If you do not receive your invoice by December 23,
2011, please contact Beverly Friedman at 301-796-3602
(12/16/2011)
- FDA Drug
Safety Communication:
Revised dose limitation for Zocor (simvastatin) when taken with
amiodarone
(12/15/2011)
- PDUFA
Meetings:
Comments Submitted to the PDUFA Public Meeting Docket
(FDA-2010-N-0128) for 10/24/2011 Meeting
(12/15/2011)
- FDA Drug
Safety Communication:
Selective serotonin reuptake inhibitor (SSRI)
antidepressant use during pregnancy and reports of a rare heart and
lung condition in newborn babies
(Posted:12/14/2011)
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Orange Book: November 2011: Additions and Deletiions to
the Drug Product List (PDF - 101KB) (Updated 12/14/2011)
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Orange Book Updated (Updated 12/14/2011)
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OGD Suitability Tracking Reports
(updated 12/13/2011)
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